Protocol Navigator II

Location: USA; currently remote with potential return to office. Attendance at virtual and in-person meetings at the NIH campus in Bethesda, Maryland is required.

Salary: $92,900–$133,215 per year.

Company

hirify.global, operated by Leidos Biomedical Research, supports biomedical research, cancer and AIDS programs, drug development, clinical trials, nanotechnology in medicine, and infectious disease response.

What you will do

• Provide protocol development and implementation support for NIAID intramural clinical research conducted domestically and internationally.
• Manage an assigned portfolio of multiple protocols, serving as the project manager and primary point of contact.
• Coordinate meetings with Principal Investigators and research staff, establish timelines, and manage protocol start-up logistics.
• Draft, review, and revise protocols and informed consent documents with medical writers and investigators.
• Prepare and coordinate submissions to scientific review committees, IRBs, radiation safety offices, and other approving bodies.
• Interpret regulatory requirements, troubleshoot human subjects protection issues, track approvals, and communicate required actions across research and regulatory groups.

Requirements

• Bachelor’s degree in biomedical research, clinical trials, health, or a related field, or four years of related experience in lieu of a degree.
• At least two years of progressively responsible biomedical research experience, including at least one year overseeing multiple concurrent projects or protocols.
• Proficiency in clinical research regulatory and human subjects protection standards, including HHS regulations.
• Familiarity with protocol and informed consent documents and the approvals required to initiate studies.
• Ability to work independently and collaboratively, assess project needs, prioritize shifting workloads, establish timelines, and meet tight deadlines.
• Proficiency with Microsoft Word, including Track Changes, and MS Office; ability to obtain and maintain a security clearance.

Nice to have

• Familiarity with allergy and infectious disease research.
• Study coordination or clinical research project management experience.
• Registered Nurse qualification.

Culture & Benefits

• Values include accountability, compassion, collaboration, dedication, integrity, and versatility.
• Remote work is currently available, with potential future return to office.
• Benefits include health and wellness programs, income protection, paid leave, retirement, and competitive compensation.
• Work supports high-quality clinical research, regulatory compliance, data integrity, and protection of human subjects.